MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) followed up with the customer over the phone to address the reported event.Fse instructed the customer on performing a decontamination on the analyzer.The customer successfully performed calibration and qc after analyzer decontamination.No further action required by field service.The customer confirmed the aia-360 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4) and progiii lot b31c314.There were two (2) similar complaints identified during the searched period for this analyzer and out of range high progiii, but the first for progiii lot b31c314.The aia-360 operator's manual under chapter 10: daily maintenance procedure provides detailed system maintenance procedure.The most probable cause of the reported event is due to biologically decontamination of the system.

Event Description

A customer reported out of range quality control (qc) for beta human chorionic gonadotropin (bhcg), estradiol (e2) and progesterone (progiii) on the aia-360 analyzer.The customer stated last system decontamination was performed (b)(6) 2021.While troubleshooting, technical support specialist (tss) confirmed the bhcg and e2 were within range, and only progiii was out of range.Tss sent mac controls to the customer for investigation and a field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for progesterone.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-360
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12808555
• MDR Text Key: 285963079
• Report Number: 3004529019-2021-00065
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1